[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63548-63549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22325]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0093; FRL-10015-11]


Pesticides; Draft Guidance for Waiving Acute Dermal Toxicity 
Tests for Pesticide Technical Chemicals and Supporting Retrospective 
Analysis; Notice of Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and seeking public comment on a draft guidance document 
entitled ``Guidance for Waiving Acute Dermal Toxicity Tests for 
Pesticide Technical Chemicals & Supporting Retrospective Analysis.'' 
Guidance documents are issued by the Office of Pesticide Programs (OPP) 
to inform pesticide registrants and other interested persons about 
important policies, procedures, and registration related decisions, and 
serve to provide guidance to pesticide registrants and OPP personnel. 
This draft guidance document provides information to pesticide 
registrants concerning the Agency's consideration to expand the 
potential for data waivers for acute dermal studies to single technical 
active ingredients (technical AIs) used to formulate end use products. 
The reasoning and analysis in this dermal waiver guidance for technical 
active ingredients is similar to what was presented in the 2016 
guidance for end-use products. While more acute toxicity studies are 
submitted to OPP annually for formulated pesticide products than for 
technical AIS, there is still the potential for animal and resource 
savings from waivers for acute toxicity studies.

DATES: Comments must be received on or before November 9, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2016-0093, though the Federal eRulemaking Portal 
at http://www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Tara Flint, Antimicrobial Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 347-0398; email address: flint.tara@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons

[[Page 63549]]

who are or may be required to conduct testing of chemical substances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other 
entities may also be interested, the Agency has not attempted to 
describe all the specific entities that may be affected by this action. 
If you have any questions regarding the applicability of this action to 
a particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

C. How can I get copies of this document and other related information?

    A copy of the draft guidance document is available in the docket 
under docket ID number EPA-HQ-OPP-2016-0093.

II. What action is the Agency taking?

A. Authority

    This guidance is provided under the authority of FIFRA (7 U.S.C. 
136 et seq.) and addresses the utility of the acute dermal toxicity 
study for single technical chemicals in pesticide labelling, such as 
the signal word and precautionary statements as described in 40 CFR 
156.64 and 40 CFR 156.70.

B. Background

    EPA's OPP regularly receives acute lethality studies for oral, 
dermal and inhalation routes along with eye irritation, skin 
irritation, and skin sensitization--these data are required for both 
the registration of new and reregistration of existing pesticidal 
products.
    In 2016, OPP published the ``Guidance for Waiving Acute Dermal 
Toxicity Tests for Pesticide Formulations & Supporting Retrospective 
Analysis'' to support the Agency's goal to reduce unnecessary animal 
testing. The retrospective analysis supports the conclusion that the 
dermal acute toxicity study for formulations provides little to no 
added value in regulatory decision making.
    In 2017 Canada's Pest Management Regulatory Agency (PMRA) released 
their Acute Dermal Toxicity Waiver. This policy includes both end use 
products and technical active ingredients. Stakeholders have requested 
that EPA expand its waiver guidance for technical active ingredients to 
support North American harmonization.
    In 2019 EPA Administrator Wheeler directed Agency leadership to 
prioritize animal testing reduction efforts.
    This draft guidance document will expand the potential for data 
waivers for acute dermal studies to single active ingredient technical 
chemicals (technical chemicals) used to formulate end use products. The 
reasoning and analysis in this dermal waiver guidance for technical 
chemicals is similar to what was presented in the 2016 guidance for 
end-use products. While more acute toxicity studies are submitted to 
OPP annually for formulated pesticide products than for technical 
chemicals, there is still the potential for animal and resource savings 
from waivers for technical chemical acute toxicity studies. Further, 
this guidance would allow EPA to harmonize with the PMRA.

III. Do guidance documents contain binding requirements?

    As guidance, this document is not binding on the Agency or any 
outside parties, and the Agency may depart from it where circumstances 
warrant and without prior notice. While EPA has made every effort to 
ensure the accuracy of the discussion in the guidance, the obligations 
of EPA and the regulated community are determined by statutes, 
regulations, or other legally binding documents. In the event of a 
conflict between the discussion in the guidance document and any 
statute, regulation, or other legally binding document, the guidance 
document would not be controlling.

    Authority: 7 U.S.C. 136 et seq.

    Dated: October 2, 2020.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2020-22325 Filed 10-7-20; 8:45 am]
BILLING CODE 6560-50-P


